Phase 1 Study of HS-10382 Oral Treatment for Chronic Myeloid Leukemia with T315I Mutation or Resistance to Previous Therapy

What this Trial Is About

Researchers are evaluating HS-10382, an oral small molecule that inhibits the BCR-ABL1 protein by locking it into an inactive form, in patients with chronic myeloid leukemia CML. This study focuses on patients with CML in chronic or accelerated phases, including those with the T315I mutation. The goal is to investigate the safety, how the drug moves through the body, and its effect on CML, especially in those resistant or intolerant to previous treatments. This open-label study has two parts a dose escalation phase with five increasing dose groups to find the safest and most effective dose, followed by a dose expansion phase to further assess safety and efficacy at the recommended dose. Participants receive HS-10382 orally once daily in both phases. Patients will be monitored closely for side effects and disease status, with the option to continue treatment if the drug is tolerated and disease remains stable or improves. During the study, participants will undergo regular assessments including blood tests to measure hematologic, molecular, and cytogenetic responses at specified intervals. Safety will be monitored continuously during treatment and for 28 days after the last dose. Researchers will also track how the drug is absorbed and processed in the body. Outcome measures include maximum tolerated dose, response rates at 6 months, and long-term survival outcomes up to 24 months. The total study may last several months with ongoing safety and efficacy evaluations.

A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.